BICARB MIXING AND DISTRIBUTION SYSTEM


Device Classification Name

tank, holding, dialysis

510(k) Number K112427
Device Name BICARB MIXING AND DISTRIBUTION SYSTEM
Applicant
ISOPURE CORP.
141 citizens blvd.
simpsonville, 
KY 
40067 -6548

Applicant Contact kevin c gillespie
Correspondent
ISOPURE CORP.
141 citizens blvd.
simpsonville, 
KY 
40067 -6548

Correspodent Contact kevin c gillespie
Regulation Number 876.5820
Classification Product Code
FIN  
Date Received 08/23/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No